DOCSLIB.ORG

CONCERTA® (Methylphenidate Hcl) Extended-Release Tablets CII

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
CONCERTA® (Methylphenidate Hcl) Extended-Release Tablets CII CONCERTA® (methylphenidate HCl) Extended-release Tablets CII DESCRIPTION CONCERTA® is a central nervous system (CNS) stimulant. CONCERTA® is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2•HCl. Its structural formula is: OOCH3 H ·HCl N Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. CONCERTA® also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin. System Components and Performance CONCERTA® uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug concentration gradient incorporated into the two drug layers of CONCERTA®. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that CONCERTA® extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. CLINICAL PHARMACOLOGY Pharmacodynamics Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Pharmacokinetics Absorption Methylphenidate is readily absorbed. Following oral administration of CONCERTA®, plasma methylphenidate concentrations increase rapidly reaching an initial maximum at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours after which a gradual decrease begins. Mean times to reach peak plasma concentrations across all doses of CONCERTA® occurred between 6 to 10 hours. CONCERTA® qd minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate tid (see Figure 1). The relative bioavailability of CONCERTA® qd and methylphenidate tid in adults is comparable. FIGURE 1 5 CONCERTA ® 18 mg qd 4 Methylphenidate 5 mg tid 3 2 1 Concentration (ng/mL) Mean Plasma Methylphenidate Methylphenidate Plasma Mean 0 0 4 8 12 16 20 24 28 32 Time (h) Figure 1. Mean methylphenidate plasma concentrations in 36 adults, following a single dose of CONCERTA® 18 mg qd and immediate-release methylphenidate 5 mg tid administered every 4 hours The mean pharmacokinetic parameters in 36 adults following the administration of CONCERTA® 18 mg qd and methylphenidate 5 mg tid are summarized in Table 1. TABLE 1: Mean ± SD Pharmacokinetic Parameters Parameters CONCERTA® Methylphenidate (18 mg qd) (5 mg tid) (n=36) (n=35) Cmax (ng/mL) 3.7 ± 1.0 4.2 ± 1.0 Tmax (h) 6.8 ± 1.8 6.5 ± 1.8 AUCinf (ng•h/mL) 41.8 ± 13.9 38.0 ± 11.0 t½ (h) 3.5 ± 0.4 3.0 ± 0.5 No differences in the pharmacokinetics of CONCERTA® were noted following single and repeated once-daily dosing indicating no significant drug accumulation. The AUC and t1/2 following repeated once-daily dosing are similar to those following the first dose of CONCERTA® 18 mg. Dose Proportionality Following administration of CONCERTA® in single doses of 18, 36, and 54 mg/day to adults, Cmax and AUC (0-inf) of d-methylphenidate were proportional to dose, whereas l-methylphenidate Cmax and AUC (0-inf) increased disproportionately with respect to dose. Following administration of CONCERTA®, plasma concentrations of the l-isomer were approximately 1/40th the plasma concentrations of the d-isomer. In a multiple-dose study in adolescent ADHD patients aged 13 to 16 administered ® their prescribed dose (18 to 72 mg/day) of CONCERTA , mean Cmax and AUCTAU of d- and total methylphenidate increased proportionally with respect to dose. Distribution Plasma methylphenidate concentrations in adults and adolescents decline biexponentially following oral administration. The half-life of methylphenidate in adults and adolescents following oral administration of CONCERTA® was approximately 3.5 h. Metabolism and Excretion In humans, methylphenidate is metabolized primarily by de-esterification to α- phenyl-piperidine acetic acid (PPA), which has little or no pharmacologic activity. In adults the metabolism of CONCERTA® qd as evaluated by metabolism to PPA is similar to that of methylphenidate tid. The metabolism of single and repeated once-daily doses of CONCERTA® is similar. After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose. Food Effects In patients, there were no differences in either the pharmacokinetics or the pharmacodynamic performance of CONCERTA® when administered after a high fat breakfast. There is no evidence of dose dumping in the presence or absence of food. Special Populations Gender ® In healthy adults, the mean dose-adjusted AUC (0-inf) values for CONCERTA were 36.7 ng•h/mL in men and 37.1 ng•h/mL in women, with no differences noted between the two groups. Race ® In adults receiving CONCERTA , dose-adjusted AUC(0-inf) was consistent across ethnic groups; however, the sample size may have been insufficient to detect ethnic variations in pharmacokinetics. Age Increase in age resulted in increased apparent oral clearance (CL/F) (58% increase in adolescents compared to children). Some of these differences could be explained by body weight differences among these populations. This suggests that subjects with higher body weight may have lower exposures of total methylphenidate at similar doses. The pharmacokinetics of CONCERTA® has not been studied in children less than 6 years of age. Renal Insufficiency There is no experience with the use of CONCERTA® in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of PPA. Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of CONCERTA®. Hepatic Insufficiency There is no experience with the use of CONCERTA® in patients with hepatic insufficiency. CLINICAL STUDIES CONCERTA® was demonstrated to be effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in 4 randomized, double-blind, placebo-controlled studies in children and adolescents who met the Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD. Children Three double blind, active- and placebo-controlled studies were conducted in 416 children aged 6 to 12. The controlled studies compared CONCERTA® given qd (18, 36, or 54 mg), methylphenidate given tid over 12 hours (15, 30, or 45 mg total daily dose), and placebo in two single-center, 3-week crossover studies (Studies 1 and 2) and in a multicenter, 4-week, parallel-group comparison (Study 3). The primary comparison of interest in all three trials was CONCERTA® versus placebo. Symptoms of ADHD were evaluated by community schoolteachers using the Inattention / Overactivity with Aggression (IOWA) Conners scale. Statistically significant reduction in the Inattention / Overactivity subscale versus placebo was shown consistently across all three controlled studies for CONCERTA®. The scores for CONCERTA® and placebo for the three studies are presented in Figure 2. FIGURE 2 Mean (SEM) Community School Teacher IOWA Conners Inattention/Overactivity Scores Maximum 15 Symptoms ® CONCERTA qd Placebo 12 9 6 3 Inattention/Overactivity Scale No Symptoms 0 (n=61) (61) (67) (67) (90) (81) Study 1 Study 2 Study 3 (Week 4) Figure 2. Mean Community School Teacher IOWA Conners Inattention/Overactivity Scores with CONCERTA® once-daily (18, 36,
Load more

Recommended publications
  • Methylphenidate Hydrochloride
    Application for Inclusion to the 22nd Expert Committee on the Selection and Use of Essential Medicines: METHYLPHENIDATE HYDROCHLORIDE December 7, 2018 Submitted by: Patricia Moscibrodzki, M.P.H., and Craig L. Katz, M.D. The Icahn School of Medicine at Mount Sinai Graduate Program in Public Health New York NY, United States Contact: [email protected] TABLE OF CONTENTS Page 3 Summary Statement Page 4 Focal Point Person in WHO Page 5 Name of Organizations Consulted Page 6 International Nonproprietary Name Page 7 Formulations Proposed for Inclusion Page 8 International Availability Page 10 Listing Requested Page 11 Public Health Relevance Page 13 Treatment Details Page 19 Comparative Effectiveness Page 29 Comparative Safety Page 41 Comparative Cost and Cost-Effectiveness Page 45 Regulatory Status Page 48 Pharmacoepial Standards Page 49 Text for the WHO Model Formulary Page 52 References Page 61 Appendix – Letters of Support 2 1. Summary Statement of the Proposal for Inclusion of Methylphenidate Methylphenidate (MPH), a central nervous system (CNS) stimulant, of the phenethylamine class, is proposed for inclusion in the WHO Model List of Essential Medications (EML) & the Model List of Essential Medications for Children (EMLc) for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) under ICD-11, 6C9Z mental, behavioral or neurodevelopmental disorder, disruptive behavior or dissocial disorders. To date, the list of essential medications does not include stimulants, which play a critical role in the treatment of psychotic disorders. Methylphenidate is proposed for inclusion on the complimentary list for both children and adults. This application provides a systematic review of the use, efficacy, safety, availability, and cost-effectiveness of methylphenidate compared with other stimulant (first-line) and non-stimulant (second-line) medications.
    [Show full text]
  • Free PDF Download
    European Review for Medical and Pharmacological Sciences 2019; 23: 3-15 Use of cognitive enhancers: methylphenidate and analogs J. CARLIER1, R. GIORGETTI2, M.R. VARÌ3, F. PIRANI2, G. RICCI4, F.P. BUSARDÒ2 1Unit of Forensic Toxicology, Sapienza University of Rome, Rome, Italy 2Section of Legal Medicine, Universita Politecnica delle Marche, Ancona, Italy 3National Centre on Addiction and Doping, Istituto Superiore di Sanità, Rome, Italy 4School of Law, University of Camerino, Camerino, Italy Abstract. – OBJECTIVE: In the last decades, phenidate analogs should be undertaken to re- several cognitive-enhancing drugs have been duce the uprising threat, and education efforts sold onto the drug market. Methylphenidate and should be made among high-risk populations. analogs represent a sub-class of these new psy- choactive substances (NPS). We aimed to re- Key Words: view the use and misuse of methylphenidate and Cognitive enhancers, Methylphenidate, Ritalin, Eth- analogs, and the risk associated. Moreover, we ylphenidate, Methylphenidate analogs, New psycho- exhaustively reviewed the scientific data on the active substances. most recent methylphenidate analogs (methyl- phenidate and ethylphenidate excluded). MATERIALS AND METHODS: Literature Introduction search was performed on methylphenidate and analogs, using specialized search engines ac- cessing scientific databases. Additional reports Consumption of various pharmaceutical drugs were retrieved from international agencies, in- by healthy individuals in an attempt to improve stitutional websites, and drug user forums. cognitive faculties is on the rise, whether for aca- RESULTS: Methylphenidate/Ritalin has been demic or recreational purposes1. These substances used for decades to treat attention deficit disor- are stimulants that preferentially target the cate- ders and narcolepsy. More recently, it has been used as a cognitive enhancer and a recreation- cholamines of the prefrontal cortex of the brain to al drug.
    [Show full text]
  • FSI-D-16-00226R1 Title
    Elsevier Editorial System(tm) for Forensic Science International Manuscript Draft Manuscript Number: FSI-D-16-00226R1 Title: An overview of Emerging and New Psychoactive Substances in the United Kingdom Article Type: Review Article Keywords: New Psychoactive Substances Psychostimulants Lefetamine Hallucinogens LSD Derivatives Benzodiazepines Corresponding Author: Prof. Simon Gibbons, Corresponding Author's Institution: UCL School of Pharmacy First Author: Simon Gibbons Order of Authors: Simon Gibbons; Shruti Beharry Abstract: The purpose of this review is to identify emerging or new psychoactive substances (NPS) by undertaking an online survey of the UK NPS market and to gather any data from online drug fora and published literature. Drugs from four main classes of NPS were identified: psychostimulants, dissociative anaesthetics, hallucinogens (phenylalkylamine-based and lysergamide-based materials) and finally benzodiazepines. For inclusion in the review the 'user reviews' on drugs fora were selected based on whether or not the particular NPS of interest was used alone or in combination. NPS that were use alone were considered. Each of the classes contained drugs that are modelled on existing illegal materials and are now covered by the UK New Psychoactive Substances Bill in 2016. Suggested Reviewers: Title Page (with authors and addresses) An overview of Emerging and New Psychoactive Substances in the United Kingdom Shruti Beharry and Simon Gibbons1 Research Department of Pharmaceutical and Biological Chemistry UCL School of Pharmacy
    [Show full text]
  • Comparison of the Inhibitory and Excitatory Effects of ADHD Medications Methylphenidate and Atomoxetine on Motor Cortex
    Neuropsychopharmacology (2006) 31, 442–449 & 2006 Nature Publishing Group All rights reserved 0893-133X/06 $30.00 www.neuropsychopharmacology.org Comparison of the Inhibitory and Excitatory Effects of ADHD Medications Methylphenidate and Atomoxetine on Motor Cortex ,1 2 3 1 1 4 Donald L Gilbert* , Keith R Ridel , Floyd R Sallee , Jie Zhang , Tara D Lipps and Eric M Wassermann 1 2 Division of Neurology, Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA; University of Cincinnati 3 4 School of Medicine, Cincinnati, OH, USA; Division of Psychiatry, University of Cincinnati, Cincinnati, OH, USA; Brain Stimulation Unit, National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA Stimulant and norepinephrine (NE) reuptake inhibitor medications have different effects at the neuronal level, but both reduce symptoms of attention deficit hyperactivity disorder (ADHD). To understand their common physiologic effects and thereby gain insight into the neurobiology of ADHD treatment, we compared the effects of the stimulant methylphenidate (MPH) and NE uptake inhibitor atomoxetine (ATX) on inhibitory and excitatory processes in human cortex. Nine healthy, right-handed adults were given a single, oral dose of 30 mg MPH and 60 mg ATX at visits separated by 1 week in a randomized, double-blind crossover trial. We used paired and single transcranial magnetic stimulation (TMS) of motor cortex to measure conditioned and unconditioned motor-evoked potential amplitudes at inhibitory (3 ms) and facilitatory (10 ms) interstimulus intervals (ISI) before and after drug administration. Data were analyzed with repeated measures, mixed model regression. We also analyzed our findings and the published literature with meta-analysis software to estimate treatment effects of stimulants and NE reuptake inhibitors on these TMS measures.
    [Show full text]
  • Methylphenidate Amplifies the Potency and Reinforcing Effects Of
    ARTICLE Received 1 Aug 2013 | Accepted 7 Oct 2013 | Published 5 Nov 2013 DOI: 10.1038/ncomms3720 Methylphenidate amplifies the potency and reinforcing effects of amphetamines by increasing dopamine transporter expression Erin S. Calipari1, Mark J. Ferris1, Ali Salahpour2, Marc G. Caron3 & Sara R. Jones1 Methylphenidate (MPH) is commonly diverted for recreational use, but the neurobiological consequences of exposure to MPH at high, abused doses are not well defined. Here we show that MPH self-administration in rats increases dopamine transporter (DAT) levels and enhances the potency of MPH and amphetamine on dopamine responses and drug-seeking behaviours, without altering cocaine effects. Genetic overexpression of the DAT in mice mimics these effects, confirming that MPH self-administration-induced increases in DAT levels are sufficient to induce the changes. Further, this work outlines a basic mechanism by which increases in DAT levels, regardless of how they occur, are capable of increasing the rewarding and reinforcing effects of select psychostimulant drugs, and suggests that indivi- duals with elevated DAT levels, such as ADHD sufferers, may be more susceptible to the addictive effects of amphetamine-like drugs. 1 Department of Physiology and Pharmacology, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA. 2 Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada M5S1A8. 3 Department of Cell Biology, Medicine and Neurobiology, Duke University Medical Center, Durham, North Carolina 27710, USA. Correspondence and requests for materials should be addressed to S.R.J. (email: [email protected]). NATURE COMMUNICATIONS | 4:2720 | DOI: 10.1038/ncomms3720 | www.nature.com/naturecommunications 1 & 2013 Macmillan Publishers Limited.
    [Show full text]
  • Methylphenidate-Induced Dendritic Spine Formation and ⌬Fosb Expression in Nucleus Accumbens
    Methylphenidate-induced dendritic spine formation and ⌬FosB expression in nucleus accumbens Yong Kima, Merilee A. Teylana, Matthew Barona, Adam Sandsa, Angus C. Nairna,b, and Paul Greengarda,1 aLaboratory of Molecular and Cellular Neuroscience, The Rockefeller University, 1230 York Avenue, New York, NY 10065; and bDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT 06508. Contributed by Paul Greengard, December 23, 2008 (sent for review December 3, 2008) Methylphenidate is the psychostimulant medication most com- dopamine and glutamate is within the dendritic spines of MSN, and monly prescribed to treat attention deficit hyperactivity disorder notably chronic exposure to psychostimulants has been found to (ADHD). Recent trends in the high usage of methylphenidate for increase the number of dendritic branch points and spines of MSN both therapeutic and nontherapeutic purposes prompted us to in NAcc (17, 18). investigate the long-term effects of exposure to the drug on GABAergic MSN, which represent 90–95% of all neurons in neuronal adaptation. We compared the effects of chronic methyl- striatum, are comprised of 2 intermingled subpopulations. One phenidate or cocaine (15 mg/kg, 14 days for both) exposure in mice subpopulation of MSN express high levels of dopamine D1 recep- on dendritic spine morphology and ⌬FosB expression in medium- tors (together with substance P and dynorphin) (MSN-D1), and the sized spiny neurons (MSN) from ventral and dorsal striatum. other MSN express high levels of dopamine D2 receptors (together Chronic methylphenidate increased the density of dendritic spines with enkephalin) (MSN-D2) (19–22). Through the use of selective in MSN-D1 (MSN-expressing dopamine D1 receptors) from the core agonists and antagonists, both D1 and D2 receptors have been and shell of nucleus accumbens (NAcc) as well as MSN-D2 (MSN- shown to be required for psychostimulant-dependent behavioral expressing dopamine D2 receptors) from the shell of NAcc.
    [Show full text]
  • Synthetic Cathinones ("Bath Salts")
    Synthetic Cathinones ("Bath Salts") What are synthetic cathinones? Synthetic cathinones, more commonly known as "bath salts," are synthetic (human- made) drugs chemically related to cathinone, a stimulant found in the khat plant. Khat is a shrub grown in East Africa and southern Arabia, and people sometimes chew its leaves for their mild stimulant effects. Synthetic variants of cathinone can be much stronger than the natural product and, in some cases, very dangerous (Baumann, 2014). In Name Only Synthetic cathinone products Synthetic cathinones are marketed as cheap marketed as "bath salts" should substitutes for other stimulants such as not be confused with products methamphetamine and cocaine, and products such as Epsom salts that people sold as Molly (MDMA) often contain synthetic use during bathing. These cathinones instead (s ee "Synthetic Cathinones bathing products have no mind- and Molly" on page 3). altering ingredients. Synthetic cathinones usually take the form of a white or brown crystal-like powder and are sold in small plastic or foil packages labeled "not for human consumption." Also sometimes labeled as "plant food," "jewelry cleaner," or "phone screen cleaner," people can buy them online and in drug paraphernalia stores under a variety of brand names, which include: Flakka Bloom Cloud Nine Lunar Wave Vanilla Sky White Lightning Scarface Image courtesy of www.dea.gov/pr/multimedia- library/image-gallery/bath-salts/bath-salts04.jpg Synthetic Cathinones • January 2016 • Page 1 How do people use synthetic cathinones? People typically swallow, snort, smoke, or inject synthetic cathinones. How do synthetic cathinones affect the brain? Much is still unknown about how synthetic cathinones affect the human brain.
    [Show full text]
  • Illicit Methylphenidate Use in an Undergraduate Student Sample: Prevalence and Risk Factors
    Illicit Methylphenidate Use in an Undergraduate Student Sample: Prevalence and Risk Factors Christian J. Teter, Pharm.D., Sean Esteban McCabe, Ph.D., Carol J. Boyd, Ph.D., and Sally K. Guthrie, Pharm.D. Study Objectives. To assess the prevalence of illicit methylphenidate use among undergraduate college students at a large university, and to identify alcohol and other drug use behaviors, as well as the negative consequences and risk factors, associated with illicit methylphenidate use. Design. Internet survey. Setting. Large public university. Subjects. Thirty-five hundred randomly selected undergraduate students. Measurements and Main Results. Of the 2250 students who completed the survey, 3% reported past-year illicit methylphenidate use. Illicit methylphenidate users were significantly more likely to use alcohol and drugs and report adverse alcohol- and drug-related consequences than prescription stimulant users or students who did not use stimulants. Undergraduate men and women were equally likely to report past-year illicit methylphenidate use. Weekly party behavior was significantly associated with past-year illicit methylphenidate use. Conclusion. Illicit use of prescription-only stimulants on college campuses is a potentially serious public health issue. More work is needed to promote understanding and awareness of this problem among clinicians and researchers. (Pharmacotherapy 2003;23(5):609–617) The misuse of alcohol and illicit drugs among Recent years have brought increasing evidence traditional-age undergraduate students
    [Show full text]
  • Advisory Council on the Misuse of Drugs
    ACMD Advisory Council on the Misuse of Drugs Chair: Dr Owen Bowden-Jones Secretary: Zahi Sulaiman 1st Floor (NE), Peel Building 2 Marsham Street London SW1P 4DF Tel: 020 7035 1121 [email protected] Sarah Newton MP Minister for Vulnerability, Safeguarding and Countering Extremism Home Office 2 Marsham Street London SW1P 4DF 10 March 2017 Dear Minister, RE: Further advice on methylphenidate-related NPS In February 2016, my predecessor Professor Les Iversen wrote to the then minister for Preventing Abuse, Exploitation and Crime, requesting that the Temporary Class Drug Order (TCDO) on seven methylphenidate-related Novel Psychoactive Substances be re-laid for a further 12 months. This TCDO was re-laid until June 2017, to allow the Advisory Council on the Misuse of Drugs (ACMD) more time to collect the evidence required to provide further advice for full control under the Misuse of Drugs Act 1971. The ACMD believes that the TCDO has been effective in reducing the prevalence of these substances and that the TCDO level of control was proportionate in the interim. I am now pleased to present to you the ACMD’s further advice on this matter in the enclosed report. The ACMD’s recommendation for full control applies to the seven substances currently controlled under the TCDO and extends to an additional five closely-related substances. These five similar substances have subsequently appeared on markets following the TCDO and are included in this advice due to their potential for similar harms. Recommendation The ACMD recommends that the
    [Show full text]
  • WHO Expert Committee on Drug Dependence
    WHO Technical Report Series 1034 This report presents the recommendations of the forty-third Expert Committee on Drug Dependence (ECDD). The ECDD is responsible for the assessment of psychoactive substances for possible scheduling under the International Drug Control Conventions. The ECDD reviews the therapeutic usefulness, the liability for abuse and dependence, and the public health and social harm of each substance. The ECDD advises the Director-General of WHO to reschedule or to amend the scheduling status of a substance. The Director-General will, as appropriate, communicate the recommendations to the Secretary-General of the United Nations, who will in turn communicate the advice to the Commission on Narcotic Drugs. This report summarizes the findings of the forty-third meeting at which the Committee reviewed 11 psychoactive substances: – 5-Methoxy-N,N-diallyltryptamine (5-MeO-DALT) WHO Expert Committee – 3-Fluorophenmetrazine (3-FPM) – 3-Methoxyphencyclidine (3-MeO-PCP) on Drug Dependence – Diphenidine – 2-Methoxydiphenidine (2-MeO-DIPHENIDINE) Forty-third report – Isotonitazene – MDMB-4en-PINACA – CUMYL-PEGACLONE – Flubromazolam – Clonazolam – Diclazepam The report also contains the critical review documents that informed recommendations made by the ECDD regarding international control of those substances. The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO’s constitutional functions is to provide objective, reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications. The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world.
    [Show full text]
  • What Every Clinician Should Know Before Starting a Patient on Meds
    CARING FOR CHILDREN WITH ADHD: A RESOURCE TOOLKIT FOR CLINICIANS, 2ND EDITION Basic Facts: What Every Clinician Should Know Before Starting a Patient on Medication Studies have shown that treatment for attention-deficit/ • If you reach the maximum recommended dose without • hyperactivity disorder (ADHD) with medication is effective in noticeable improvement in symptoms, try a different stimulant treating the symptoms of ADHD alone or in combination with medication class. Approximately 80% of children will respond to behavioral interventions. at least 1 of the 2 stimulant classes tried. • Stimulant medications also improve academic productivity but • When changing medications, be careful about the dose not cognitive abilities or academic skills. equivalence of different stimulant medication classes; in general, equivalent doses for dexmethylphenidate and Stimulants can help reduce oppositional, aggressive, impulsive, • amphetamine-based stimulants are approximately half of a and delinquent behaviors in some children. methylphenidate dose. Several types of medications are Food and Drug Administration Non-stimulant medications may require 2 or more weeks to see • (FDA)-approved for the treatment of ADHD. • effects, so you should titrate up more slowly than you would • Stimulant medications: methylphenidate, dexmethylphenidate, for stimulant medications. Obtaining follow-up rating scales is dextroamphetamine, mixed amphetamine salts, even more important than for stimulant medications because lisdexamfetamine changes are more gradual. • Non-stimulant medications: atomoxetine, and extended-release • Managing side effects effectively can improve adherence to and guanfacine and clonidine satisfaction with stimulant medications. When choosing which stimulant and dose to start first, consider • Common side effects to discuss with families include • stomachache, headache, decreased appetite, sleep problems, Family preference and experience with the medication, including • and behavioral rebound.
    [Show full text]
  • Do You Know... Cocaine
    Do You Know... Street names: blow, C, coke, crack, flake, freebase, rock, snow Cocaine What is cocaine? Cocaine is a stimulant drug. Stimulants make people feel more alert and energetic. Cocaine can also make people feel euphoric, or “high.” Pure cocaine was first isolated from the leaves of the coca bush in 1860. Researchers soon discovered that cocaine numbs whatever tissues it touches, leading to its use as a local anesthetic. Today, we mostly use synthetic anesthetics, rather than cocaine. In the 1880s, psychiatrist Sigmund Freud wrote scientific papers that praised cocaine as a treatment for many ailments, including depression and alcohol and opioid addiction. After this, cocaine became widely and legally available in patent medicines and soft drinks. As cocaine use increased, people began to discover its dangers. In 1911, Canada passed laws restricting the importation, manufacture, sale and possession of cocaine. The use of 1/4 © 2003, 2010 CAMH | www.camh.ca cocaine declined until the 1970s, when it became known How does cocaine make you feel? for its high cost, and for the rich and glamorous people How cocaine makes you feel depends on: who used it. Cheaper “crack” cocaine became available · how much you use in the 1980s. · how often and how long you use it · how you use it (by injection, orally, etc.) Where does cocaine come from? · your mood, expectation and environment Cocaine is extracted from the leaves of the Erythroxylum · your age (coca) bush, which grows on the slopes of the Andes · whether you have certain medical or psychiatric Mountains in South America.
    [Show full text]